Effect of Chinese medicine comprehensive regimen as the maintenance therapy on time to progression and quality of life of patients with advanced non-small-cell lung cancer / 中国中西医结合杂志

ABSTRACT

<p><b>OBJECTIVE</b>To observe the effect of Chinese medicine (CM) comprehensive regimen as the maintenance therapy (MT) on time to progression (TTP) and quality of life (QOL) of patients with advanced non-small-cell lung cancer (NSCLC).</p><p><b>METHODS</b>The study was a prospective, randomized and controlled clinical trial. Fifty non-progressive patients with advanced NSCLC who responded to first-line therapy were randomized into the test group (25 cases, treated with CM comprehensive regimen: intravenous dripping of Chinese herbal preparation, oral administration of Chinese herbal decoction, and point application) and the control group [25 cases, treated with one of three single-agent maintenance chemotherapy regimens: pemetrexed (500 mg/m2, day 1), docetaxel (75 mg/m2, day 1), and gemcitabine (1000 mg/mi, day 1 and day 8) in the ratio of 1:1]. Each cycle consisted of 21 days. Cycles were repeated until the disease progressed, or intolerable toxic or adverse reaction occurred, or patients refused to continue the treatment. The primary end point was TTP and the secondary end point was QOL. QOL was evaluated using the European Organization for Research and Treatment of Cancer quality-of-life questionnaire QLQ-LC43 (EORTC QLQ-LC43). TTP of fifty patients and QOL of 43 patients had been statistically analyzed.</p><p><b>RESULTS</b>(1) The TTP in the test group was prolonged for 23 days when compared with that of the control group, with insignificant difference (87 days vs 64 days, P=0.063). (2) The scores of domains in EORTC QLQ-LC43 were statistically significantly better in the test group than in the control group (P<0.05) except cognitive and social functions, the symptoms of dysphagia and pain in other parts.</p><p><b>CONCLUSIONS</b>(1) The CM comprehensive regimen as MT had equivalent efficacy on TTP when compared with single-agent maintenance chemotherapy regimen. It was advantageous over improving the QOL. (2) It is necessary to enlarge the sample size to further confirm the therapeutic efficacy of CM comprehensive regimen as MT in treatment of patients with advanced NSCLC.</p>